NARIZINE
-
Chemical Name:
Flunarizine -
Therapeutic Category:
Central nervous system drugs -
Pharmacologic Category:
Calcium Channel Antagonist -
Pharmaceutical Form:
Capsules -
Composition:
Flunarizine 5mg
NARIZINE
Capsules
Flunarizine
1.PHARMACOLOGY:
Flunarizine is a selective calcium antagonist. It prevents cellular calcium overload by reducing excessive transmembrane calcium influx.
Flunarizine has no effect on contractility or conduction of the heart.
The drug is well absorbed from the gut, reaching peak plasma levels within 2-4 hours and reaching steady state at 5-6 weeks.
After extensive hepatic metabolism, the drug and its metabolites are excreted through the faeces via the bile. The mean terminal elimination half-life is about 18 days.
Plasma protein binding is 90 %.
2.INDICATIONS:
NARIZINE is indicated in prophylaxis of classic (with aura) or common (without aura) migraine.
Symptomatic treatment of vestibular vertigo, due to a diagnosed functional disorder of the vestibular system.
3.CONTRAINDICATIONS:
Flunarizine is contraindicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson’s disease or other extrapyramidal disorders.
4.WARNINGS AND PRECAUTIONS:
This treatment may glue rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients, such as the elderly. Therefore, it should be used with caution in such patients.
In rare cases fatigue may increase progressively during Flunarizine therapy: in this event, the therapy should be discontinued.
The recommended dose should not be exceeded. Patients should be seen at regular intervals, especially during maintenance treatment, so that extrapyramidal or depressive symptoms may be detected early and if so, treatment discontinued. If, during maintenance treatment, the therapeutic effects wane, treatment should also be discontinued (for duration of treatment).
Pregnancy and nursing:
Flunarizine should be used during pregnancy only if the potential benefit to the mother justifies the unknown risk to the fetus.
Nursing should therefore be discouraged in women taking Flunarizine.
Effects on driving ability and use of machinery:
Since somnolence may occur, especially at the start of the treatment, caution should be exercised during activities such as driving or operating dangerous machinery.
5.INTERACTIONS:
Excessive sedation can occur when alcohol, hypnotics or tranquillizers are taken simultaneously with Flunarizine.
Flunarizine is not contra-indicated in patients who use beta-blocking agents.
6.ADVERSE REACTIONS:
The most frequent adverse experiences are drowsiness and/or fatigue (20%), which are generally transient, and also weight gain (and/or increased appetite) (11 %).
The following serious adverse experiences may occur during chronic treatment:
- Depression, of which female patients with a history of depressive illness may particularly heal ash.
- Extrapyramidal symptoms (such as bradykinesia, rigidity, akathisie, orofacial dyskinesia, tremor), of which elderly patients seem particularly at risk.
Infrequently reported adverse experiences are:
- Gastrointestinal: heartburn, nausea, gastralgia.
- Central nervous system: insomnia, anxiety.
- Others: galactorrhoea, dry mouth, muscle ache, skin rash.
7.DOSAGE AND ADMINISTRATION:
-
Migraine prophylaxis:
-Starting dose:
Treatment is started at 10 mg daily (at night) for patients younger than 65 years of age and at 5 mg daily for patients older than 65 years. If, during this treatment, depressive, extrapyramidal or other unacceptable adverse experiences occur, administration should be discontinued.
If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should also be discontinued.
-Maintenance treatment:
If the patient responds satisfactorily and if a maintenance treatment is needed, the dose should not be decreased so that each week he/she has 5 days treatment at the same daily dose and 2 successive drug-free days.
Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and re-initiated only if the patient relapses.
Even if the prophylactic maintenance is successful and well tolerated, it should be interrupted after 6 months and re-initiated only if the patient relapses.
-
Vertigo:
The same daily doses should be used as for migraine, but the starting treatment should not be given longer than needed tar symptom control, which generally lakes less than two months.
If, however, no significant improvement is observed after one month for chronic vertigo or after two months far paroxysmal vertigo, the patient should be considered a non-responder and administration should be discontinued.
8.OVERDOSAGE:
Symptoms:
On the basis of the pharmacological properties of the drug, sedation and asthenia may be expected to occur. A few cases of acute overdosage (up to 600 mg in one intake) have been reported and the observed symptoms were sedation, agitation and tachycardia.
Treatment:
There is no specific antidote. Within the first hour after ingestion, gastric lavage may be performed. Activated charcoal may be given if considered appropriate.
9.PACKING AND COMPOSITION:
NARIZINE 5 – Capsules: A Pack of 20 capsules. Each capsule contains 5 mg Flunarizine.
10.STORAGE CONDITIONS:
Store NARIZINE – Capsules at temperature between (15-30)°C. Protect from light.
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